University of North Carolina-Healthwise Partnership Project on Birth Options Decision Aid

Decision Making, Shared Clinical Trial

— B-READY  

Official title:

Pilot Study to Assess the Effectiveness of a Decision Tool for Cesarean Delivery vs. Trial of Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04053413
• Other study ID #: 17-2023
• Status: Completed
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is pilot quasi-experimental study of women with one or two prior cesarean deliveries who are now pregnant and eligible for a trial of labor after cesarean delivery, to assess whether a decision aid, providing knowledge about trial of labor (VBAC) and planned repeat cesarean delivery can improve the birth options decision-making process for patients.

Participants are screened for eligibility through electronic health records. Once an individual is screened eligible, and email invite is sent providing information about the study and assessing the interest in participation. An on-line consent is completed and women are entered sequentially into the usual care group and then through further recruitment, another sample of women are entered into the decision aid group. The primary outcome is satisfaction with the shared decision-making process with their provider.

Description:

Once a potential participant is screened eligible, completes the on-line informed consent, they are officially enrolled in the study and sent a link confirming their enrollment and the study group in which they have been assigned. Participants are sequentially enrolled in the study with enrollment first into the usual care group. Once enrollment in the usual care group is complete, enrollment into the decision aid group will occur.

The study includes two non-randomized groups:

Arm 1 (Usual care group): Women in this group will undergo usual care and complete the survey questions on knowledge of risks and benefits of TOLAC (also referred to as VBAC) and planned repeat cesarean (PRCS), certainty of their decision, and involvement in the decision for trial of labor (TOLAC) or repeat cesarean delivery.

Arm 2: (Decision aid group- group receiving the decision tool): Women in this group will receive a decision aid prior to undergoing counseling by their physician. Following completion of the decision aid and physician counseling, they will complete a series of survey questions to assess their knowledge of the risks and benefits of TOLAC and PRCS, certainty of their decision, and involvement in the decision for repeat cesarean or TOLAC.

The decision aid group will be compared with women who do not receive the decision aid (usual care group).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Gestational age between 19/0 and 36/6 weeks

• History of 1 or 2 prior cesarean deliveries

Exclusion Criteria:

• No contraindications to trial of labor after cesarean (TOLAC)

• No history of prior TOLAC

Related Conditions & MeSH terms

• Decision Making, Shared
• Scar; Previous Cesarean Section
• Vaginal Birth After Cesarean

Intervention

Other:
• Decision Aid
The decision aid is a series of web pages that includes videos, questions, and evidence-based information. The decision aid is designed to help women think about what matters to them and what questions they may have for their doctor or midwife. At the end, they receive a summary of which way they are leaning and what matters most to them.

Locations

Country	Name	City	State
United States	University of North Carolina - Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Healthwise

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shared Decision Making (SDM) Process score	This is a measure of the patient's involvement in the decision. 1 point is assigned for discussing the pros 'a lot' or 'some'; 1 point is assigned for discussing the cons 'a lot' or 'some'; 1 point is assigned for responding 'yes' if the provider explained the options; and 1 point is assigned for responding 'yes' that the provider asked the patient what treatment she wanted. The tool's score range is 0-4. A higher score indicates more involvement in the decision.	Up to 6 months prior to delivery
Secondary	Number of Participants (by category) With the Intent to Deliver by Repeat Cesarean Section or by Vaginal Delivery	Intended mode of delivery (repeat cesarean or vaginal) prior to actual delivery	Date of Admission
Secondary	Number of Participants (by category) who Delivered by Repeat Cesarean or Vaginal Delivery	Actual method of delivery (repeat cesarean or vaginal delivery)	Up to 72 hours after delivery
Secondary	Maternal or Fetal Complications at Delivery	Number of complication events: maternal postpartum hemorrhage, infection, fetal admission to neonatal intensive care unit.	Up to 72 hours after delivery
Secondary	Number of Participants (by Category) who desired Repeat Cesarean, Vaginal Delivery or Are Undecided after completion of the study survey	Participant responses are: 1) repeat cesarean delivery, 2) vaginal delivery and 3) undecided	Up to 6 months prior to delivery